Kornimate/medical-research-clean huggingface dataset:
shorten the time required to correct the arrival of complete oral feeding in premature infants

Conditions: Premature Infants

Summary: non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants

in order to improve the feeding of premature infants \<32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. premature infants will be assessed 12 times a day before feedings using the feeding preparation scale. assess the premature infants by using the feeding preparation scale. if the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. the whole intervention stops until the premature infant achieves the full oral feeding. length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants \<32 weeks of gestation.

Eligibility criteria:
inclusion criteria: * gestational age \<32w; * admit within 72 hours of birth; * the guardian signs the informed consent; * oi (oxygenation index \>300) exclusion criteria: * newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases; * newborns who die during the study; * newborns who drop out of the study; * newborns who have nec during hospitalization

Keywords: premature infants oral feeding
using microfluidic separation sperm selection for unexplained infertility and reccurrent implantation failure

Conditions: Unexplained Infertility; Recurrent Implantation Failure

Summary: in order to increase the likelihood of achieving ivf-treated pregnancy, good quality embryo transfer is important. to get good quality embryos, good quality gametes are needed. the selection of sperm is regulated according to the changing and mobility characteristics of today's conditions. the choice of multi-fluid sperm is thought to provide better sperm to obtain the environment in physiological conditions. better embryo transfer to achieve better sperm elongation will increase the likelihood of pregnancy.

patients will be treated with conventional ivf treatment. a vaginal ultrasound (us) examination will be perform on day 3 of the cycle for assessment of ovarian size and to exclude patients with large ovarian cysts. if a cyst \>20 mm is present, the cycle will cancel. at an initial dose of 225 iu, hmg will be given daily by im injection commencing on day 3 of the cycle. the dose will be adjusted as re- quired depending on the e2 (estradiol) level. daily endovaginal us examinations for follicle growth assessment will be started when the e2 level reached 275 pg/ml (1,000 pmoljl). when at least two follicles would reach 18 mm in diameter, 5,000 iu of hcg will be administered intramuscularly. oocyte retrieval will be performed vaginally under us guidance 36 hours later. sperm for icsi procedure of oocytes will be prepared by a standard swim-up technique using for control group and sperm chip method will be used for study group for unexplained infertility and recurrent implantation failure group. uterine transfer of embryos will be carry out fifth day after oocyte retrieval using a catheter.

Eligibility criteria:
unexplained infertility group; the inclusion criteria are; 1. normal hsg, 2. normal hormone levels, 3. normal over functions, 4. having normal uterine cavity and endometrial thickness determined by office hysteroscopy 5. no endometriosis (determined by transvaginal ultrasonography and / or diagnostic laparoscopy) 6. normal spermiogram result recurrent implantation failure the inclusion criteria are; 1-the inclusion criteria of the working group are: 2-failure of embryo transfer at least twice after high quality embryo transfer after 3-ivf treatment, 4-having normal hormone reserve (fsh \ 8 oocyte collection), 6-having normal uterine cavity and endometrial thickness determined by office hysteroscopy

Keywords: unexplained infertility recurrent implantation failure
study to assess the acceptability/swallowability of drv-containing fdc tablets in hiv-1 infected adolescents, using matching placebo tablets

Conditions: HIV-1

Summary: the primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (drv/cobi) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (d/c/f/taf) fixed-dose combination (fdc) tablets, using matching placebo tablets, in human immunodeficiency virus (hiv) -1 infected adolescent patients.


Eligibility criteria:
inclusion criteria: * participant must be male or female between 12 to 17 years of age, inclusive * participant must have a body weight of at least 40 kilogram (kg) * informed consent must be obtained (from participant and/or his/her parent(s)/legal guardian, as applicable) and an age-appropriate assent form, as applicable, indicating that the purpose of, and procedures required for, the study are understood and that the participant is willing to participate in the study * participant must be able to comply with the protocol requirements, and adhere to prohibitions and restrictions specified in the protocol * participant has documented chronic human immunodeficiency virus (hiv) -1 infection, and is aware of his/her hiv-1 diagnosis * participant must be on a stable antiretroviral (arv) regimen for at least 3 months and has documented plasma hiv-1 ribonucleic acid (rna) less than (\<) 50 copies/ millilitre (ml) within 3 months prior to screening * participant must be willing to assess swallowability of the placebo tablets and be able to do so (as demonstrated by the intake of a reference placebo tablet) exclusion criteria: * participant has any condition that, in the opinion of the investigator, would compromise the study or the well-being of the participant, or prevent the participant from meeting or performing study requirements * participant has any condition that, in the opinion of the investigator, could prevent, limit, or confound the protocol-specified assessments * participant has any active clinically significant physical or psychological disease or findings during screening that, in the investigator's opinion, would compromise the participant's safety, ability to swallow (eg, candidiasis), or outcome of the study * participant has history of difficulty with oral intake of arv therapy or other medications * participant is taking disallowed concomitant medications or over-the-counter products * participant is a family member of an employee or investigator of the study site or participant is a family member of an employee of johnson \& johnson
mitralstitch mitral valve repair system for mitral regurgitation

Conditions: Mitral Regurgitation

Summary: the main objective is to assess the effectiveness and safety of the mitralstitch repair system in patients with moderate to severe and severe mitral regurgitation.


Eligibility criteria:
inclusion criteria: 1. the age of patient is ≥18yrs; 2. severe mitral regurgitation patients (the area of central regurgitation exceeds 40% of left atrial area or holosystolic eccentric regurgitation; vc≥0.07cm；regurgitant volume ≥60ml；rf ≥50%; eroa≥0.4cm2 (satisfy any condition). 3. lvesd≤60mm, lvef≥25%, small incision surgery of chest can be tolerated. 4. the subject was informed of the clinical application nature of the new technology and agreed to participate in all requirements of the clinical application of the new technology, signed the icf and agreed to complete the follow-up and the inspection required during the follow-up period. exclusion criteria: 1. subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology. 2. subjects with active endocarditis or rheumatic mitral valve disease. 3. life expectancy \<1 year for cardiac or other malignant tumors. 4. participate in other clinical trial 5. in the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.
coping kids: early intervention for anxiety and depression

Conditions: Anxiety; Depression

Summary: the purpose of this study is to provide knowledge regarding the effect of early intervention and prevention on the development of anxiety and depression in children. the focus of the intervention is to reduce symptoms of anxiety and depression and help children develop skills to enhance self-esteem in order to improve life quality. gender and ethnicity will be studied as moderating factors. primary care givers will be trained in the use of evidence based methods for children with internalizing difficulties. children in need will be identified and receive improved services, based on international standards. active collaboration will be established nationally between three centers for child and adolescent mental health (rkbu/rbup) and internationally with philip c. kendall at the temple university in philadelphia and kevin stark at university of texas at austin. primary aims are to examine if an indicated group and school based program, coping kids, is more effective than treatment as usual (tau) in reducing high levels of symptoms of both anxiety and depression among 8-12 year old schoolchildren, and if the the effects are stable over 12 months.


Eligibility criteria:
inclusion criteria: * children at the intervention schools indicating a symptom level of, at minimum, one standard deviation above mean on anxiety and/or depression on self-report measures will be offered participation in an intervention group exclusion criteria: * children who for different reasons may not benefit from a group-process intervention (e.g. mental retardation) will be considered individually and the reasons for exclusion will be documented in the consort flow-chart.
self-directed versus therapist-directed re-loading on incidence of ulcer recurrence

Conditions: Diabetic Foot Ulcer

Summary: this study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. the people in this study will have diabetes and have a recently closed foot ulcer. about half will be specifically told how to return to walking and the other half will be told to return to walking slowly. how people naturally return to walking will also be established.

the purpose of this project is to determine the impact of therapist-directed loading versus self-selected loading on ulcer occurrence and to establish natural loading behavior following diabetic foot ulcer closure. eligible participants will be randomized into a group given specific directions from a therapist to return to walking (i.e. reloading skin following plantar ulceration closure) or a group encouraged to slowly return to walking (self-directed re-loading of the skin following plantar ulceration closure). following randomization and instruction for re-loading according to group assignment, participants will be assessed every 6 months for walking behavior. participants will be monitored for ulcer recurrence throughout. participants will be followed for up to 18 months.

Eligibility criteria:
inclusion criteria: * with or without peripheral neuropathy * able to safely exercise * have a recently closed plantar ulceration exclusion criteria: * presence of an open plantar ulceration * presence of an untreated infection * presence of osteomyelitis or gangrene

Keywords: diabetes re-loading ulcer recurrence
f-18 fdopa pet/ct versus i-123 mibg scintigraphy with spect/ct for the diagnosis of pheochromocytoma and paraganglioma

Conditions: Pheochromocytoma; Paraganglioma

Summary: pheochromocytomas and paragangliomas (ppgls) are chromaffin cells-derived tomours that originate from the adrenal medulla (80\~85%) and the extra-adrenal sympathetic paraganglia in thorax, abdomen and pelvis (15\~20%) or parasympathetic paraganglia in the head and neck region (\~1%), respectively. functional imaging, such as 123i-meta-iodobenzylguanidine (mibg) scintigraphy with single photon emission computed tomography with a ct (spect/ct), offers high specificity for ppgl but necessitates 24-hour delayed imaging, pre-processing thyroid protection with a potassium iodide solution, and medication reconciliation to prevent the inhibition of 123i-mibg uptake. conversely, 18f-l-dihydroxyphenylalanine (fdopa), a radiopharmaceutical for positron emission tomography (pet) imaging, is specifically absorbed and accumulated by chromaffin cells, offering better image quality and convenience compared to 123i-mibg scintigraphy. 18f-fdopa pet/ct has been approved for the localization, staging, and detection of ppgl recurrences in european and other countries. therefore, the aim of this study was to compare prospectively the diagnostic performances of 18f-fdopa pet/ct and 123i-mibg scintigraphy with spect/ct in patients with ppgl.


Eligibility criteria:
inclusion criteria: 1. suspected ppgl based on a biochemical screening, including 24-hour urinary total normetanephrine, metanephrine, norepinephrine, and epinephrine, along with plasma free concentrations of normetanephrine and metanephrine conducted within the past 6 months 2. an adrenal incidentaloma, suggestive of ppgl on anatomical imaging (ct or mri) performed within the past 6 months 3. characteristic symptoms and signs of ppgl 4. suspected of recurrence or metastases of known ppgl. exclusion criteria: * pregnant and lactating women * individuals aged less than 15 years * patients with a serum creatinine level greater than 3 mg/dl due to chronic renal failure * patients with a second primary cancer that was not in complete remission
milrinone pharmacokinetics and acute kidney injury

Conditions: Congenital Heart Disease; Acute Kidney Injury

Summary: acute kidney injury (aki) occurs in 40% of children following heart surgery. serum creatinine (scr) is a late biomarker of aki, rising 24-48 hours after surgery. thus, for medicines excreted in the urine, aki could potentially lead to toxic levels in the blood. urinary biomarkers have the ability to detect aki earlier. whether early detection of aki through urinary biomarkers can predict altered drug levels is unknown. milrinone is used to improve heart function after surgery, but accumulates in aki resulting in low blood pressure. dose adjustments are not currently possible because of the late rise in scr, and are based on clinical parameters that may lead to clinically relevant over or under-dosing. thus, this study will address an important knowledge gap being the first to use elevations of aki biomarker concentrations to anticipate increased milrinone levels.


Eligibility criteria:
inclusion criteria: * undergoing cardiothoracic surgery with cardiopulmonary bypass * weight greater than 2500 grams (5 pounds 8 ounces) at the time of surgery * gestational age \> 36 weeks * age less \< to 1 year * infants with complex congenital heart disease * use of milrinone in the intra-operative and post-operative period. exclusion criteria: * pre-existing kidney disease (structural and functional abnormalities) as determined by the principal investigator * use of aminoglycosides within 48 hours of planned surgery * cardiac arrest prior to cardiac surgery * extracorporeal membrane oxygenation prior to cardiac surgery * urinary tract infection prior to surgery * repair of an isolated atrial or ventricular septal defect
corticosteroids with placebo versus corticosteroids with propranolol treatment of infantile hemangiomas (ih)

Conditions: Hemangioma

Summary: this is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. we hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.

infantile hemangiomas (ih) are the most common head and neck pediatric tumors. presence of these tumors can lead to complications of vision and airway compromise, bleeding and disfigurement. medical treatment of these lesions has traditionally been focused on stopping new blood vessel growth with corticosteroids. recent reports and our own experience have demonstrated that significant reduction in ih size and vascularity can also occur through the use of propranolol. our initial experience with propranolol has demonstrated significant efficacy with fewer side effects than corticosteroids. despite this experience, the standard of care for initial ih medical therapy remains corticosteroids. this trial is a direct comparison of traditional ih therapy with corticosteroids to newer therapy with propranolol and corticosteroids.

Eligibility criteria:
inclusion criteria: * age 0 to \< 9months * patients with clinical, radiographic or histologic diagnosis of infantile hemangioma (ih) requiring medical treatment * ih patients whose parents desire medical treatment for the ih * stable cardiac function exclusion criteria: * ih patients over 9 months of age. * hypersensitivity to propranolol * untreated heart failure: if the patient has heart failure associated with the hemangioma, propranolol would be initiated after anti-congestive therapy and under observation as an in-patient. * atrioventricular (av) block * resting heart \< 2 sd of normal\*(below) * resting blood pressure \< 2 sd of normal\*\*(below) * wolff-parkinson-white syndrome (wpw) * history of unexplained syncope * bronchial asthma * history of impaired renal or liver function * diabetes mellitus
safety and efficacy study of jtt-851 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effect of jtt-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of jtt-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

this is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of jtt-851 on hba1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of jtt-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * males and females with type 2 diabetes, 18-70 years of age at visit 1 * managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day) * glycosylated hemoglobin at visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment * body mass index (bmi) ≥ 23.0 kg/m\^2 and ≤ 45.0 kg/m\^2 at visit 1 exclusion criteria: * females who are pregnant or breast-feeding * known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy * acute coronary syndrome or uncontrolled hypertension * does not meet all diet or previous/concomitant medication restriction criteria

Keywords: diabetes
vitamin d for chemoprevention

Conditions: Gastrointestinal Cancers; Prostate Cancer; Hypertension

Summary: this study will help us know the effects of vitamin d pills in blacks. the results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. it will also help us develop ways to reduce colon cancer and prostate cancer among blacks. this study will find out if vitamin d pills can increase vitamin d to healthy levels in our bodies.

* participants will be asked to answer some questions about their diet, exercise and health. in addition, participants blood pressure will be taken. these assessments will occur at baseline, 3- and 6-month appointments. at baseline only, we will measure skin tone with a tool called the photovolt 577. * a small blood sample will be taken to see how much vitamin d is the body and will also look at levels of other markers of disease such as proteins, hormones, and genes. * participants will take a vitamin pill every day for three months and be randomly assigned to one of four different types of pills. * participants will be called or visited at least every two weeks. they will be asked questions to determine if they have any side effects associated with high levels of vitamin d. * at the beginning of the second and third months, participants will be provided with more pills. at the end of the third month, another blood sample will be taken. three months after that, the final blood sample will be taken.

Eligibility criteria:
inclusion criteria: * between the ages of 30 and 80 years * comfortable communicating in english * currently has a primary care physician * willing to discontinue vitamin d or calcium supplements * willing to have all protocol specific tests run exclusion criteria: * plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend) * pregnant or breast feeding or planning on becoming pregnant in the following year * pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis * no concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer * cognitively impaired * active thyroid disease (e.g. graves, hashimoto's or thyroiditis) * history of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis

Keywords: vitamin d blacks cancer hypertension
effectiveness of facot for individuals post stroke

Conditions: Stroke

Summary: to develop and assess the effectiveness of a novel cognitive-functional intervention (facot) in occupational therapy for people after mild to moderate stroke.


Eligibility criteria:
inclusion criteria: * \>18 years * at least three years post stroke * severity mild to moderate (nihss≤5) * independent prior to the stroke * can understand and speak hebrew exclusion criteria: * with no other neurological or psychiatric conditions * without dementia
psychosis tms study

Conditions: Psychosis

Summary: the main goal of this study is to investigate the neural mechanisms of working memory function in patients with early psychosis using transcranial magnetic stimulation (tms) in conjunction with functional mri. tms is a noninvasive method used to modulate brain activity via changing magnetic fields applied over the surface of the scalp.


Eligibility criteria:
inclusion criteria: * diagnosis of psychosis, psychosis not otherwise specified, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder with psychosis, and schizophreniform disorder within first ten years of onset of psychotic symptoms. * ability to provide informed consent exclusion criteria: * tms incompatibility including metallic implants in head and neck, cardiac pacemakers, history of seizures, pregnancy. * mri-incompatibility including implanted aneurism clips, cardiac pacemakers, metal implants, intrauterine devices, tattoos containing metal ink, pregnancy, and claustrophobia * severe substance abuse within 3 months (nicotine allowed) * unstable medical or neurologic illness that would preclude participation in study procedures

Keywords: cognitive impairment transcranial magnetic stimulation attention short-term memory